The Efficacy of a Soluble Ligand Binding Tumour Necrosis Factor Receptor, Etanercept, in Severe, Steroid Dependant Asthma: a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Juniper asthma quality of life
研究概览
简要总结
The purpose of this study was to investigate whether the administration of etanercept to patients with severe asthma improved their asthma related quality of life and a measure of the degree of reactivity of the airways
详细描述
Although steroid dependent asthma represents a small population of patients with asthma, they consume a disproportionately large amount of the health resource burden attributed to asthma. Treatment options in this group are extremely limited; the development of effective treatments for this group of patients should be a priority, not only for increasing individual patient quality of life but for long term reduction of health spending.
This randomised, double blind, placebo controlled, cross over trial will investigate the efficacy of a soluble TNF receptor, etanercept, in severe, steroid dependant asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic asthma Methacholine PC20<8mg/ml
排除标准
- •History of poor treatment concordance History of tuberculosis Radiographic evidence of previous tuberculosis Recent tuberculosis contact Respiratory tract infection within 3 months Current Smoker or Ex-smoker with more than 5 pack years Symptomatic co-morbid condition Contra-indication to etanercept Pregancy Breast feeding
结局指标
主要结局
Juniper asthma quality of life
Methacholine PC20
次要结局
- Net change in post-bronchodilator FEV1
- FVC
- exhaled nitric oxide concentration
- computed alveolar nitric oxide concentration
- symptom visual analogue score
- FEF25-75
- sputum differential inflammatory cell counts
- sputum supernatant mediator concentration.